Phase
Condition
Multiple Sclerosis
Scar Tissue
Memory Loss
Treatment
Botox 100 UNT Injection
VESIcare 10Mg Tablet
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with multiple sclerosis (MS) with neurogenic detrusor overactivity provenby urodynamics
Stable MS with an Expanded Disability Severity Score (EDSS) less than or equal to 6.5
Voluntary micturitions
Number of micturitions > 8 per day, with or without episodes of urgency and urgencyincontinence
Signed informed consent form
Exclusion
Exclusion Criteria:
Pregnancy, breastfeeding
Patients requiring self-catheterizations
Patients unable or unwilling to learn self-catheterisation
Recent (<12 weeks) or current treatment with botulinum toxin for any non-urologicalindication
Recent (≤ 8 weeks) or current treatment with anticholinergic drugs
Patients with a positive history or evidence of pelvic / urological abnormality (interstitial cystitis, bladder lithiasis in the 6 months preceding the screening,or any other condition / operation affecting the bladder or prostate)
Any contraindication to Vesicare®:
Hypersensitivity to the active ingredient or to one of the excipients
Urinary retention
Untreated narrow-angle glaucoma
Severe gastrointestinal illness (e.g. toxic megacolon)
Myasthenia gravis
Severe hepatic failure
Hemodialysis
Severe renal failure, or liver function disturbances of moderate severity withconcomitant treatment with a strong inhibitor of the CYP3A4 isoenzyme,including patients at risk for these diseases.
Any contraindication to BOTOX®:
Known hypersensitivity to the active substance or to one of the excipients
Presence of a symptomatic infection at the planned injection site(s)
Urinary tract infection at the time of planned treatment
Patients who present with acute urinary retention at the time of treatment andwho do not regularly use bladder catheterization
Patients who do not want and / or cannot, if necessary, performself-intermittent catheterisation
Study Design
Study Description
Connect with a study center
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
SwitzerlandSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.